Biopsy device with central thumbwheel

ABSTRACT

A biopsy device comprises a probe and a holster. The probe has a distally extending needle including a transverse tissue receiving aperture. A cutter is translatable relative to the needle to sever tissue protruding through the aperture. A thumbwheel is manually operable to rotate the needle to reorient the angular position of the aperture about the longitudinal axis defined by the needle. The thumbwheel is positioned obliquely with the longitudinal axis. A cable driven mechanism in the holster drives the cutter. A rotatable tissue sample holder is coupled with the probe, and has chambers configured to receive tissue samples communicated proximally through a lumen defined by the cutter. A piezoelectric motor in the holster drives the tissue sample holder.

PRIORITY

The present application is a continuation of U.S. patent applicationSer. No. 12/337,942, entitled “Biopsy Device with Central Thumbwheel,”filed Dec. 18, 2008, the disclosure of which is hereby incorporated byreference in its entirety.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. Biopsy devices may beused under stereotactic guidance, ultrasound guidance, MRI guidance, PEMguidance, BSGI guidance, or otherwise. Merely exemplary biopsy devicesare disclosed in U.S. Pat. No. 5,526,822, entitled “Method and Apparatusfor Automated Biopsy and Collection of Soft Tissue,” issued Jun. 18,1996; U.S. Pat. No. 6,086,544, entitled “Control Apparatus for anAutomated Surgical Biopsy Device,” issued Jul. 11, 2000; U.S. Pub. No.2003/0109803, entitled “MRI Compatible Surgical Biopsy Device,”published Jun. 12, 2003; U.S. Pub. No. 2007/0118048, entitled “RemoteThumbwheel for a Surgical Biopsy Device,” published May 24, 2007; U.S.Pub. No. 2008/0214955, entitled “Presentation of Biopsy Sample by BiopsyDevice,” published Sep. 4, 2008; U.S. Provisional Patent ApplicationSer. No. 60/869,736, entitled “Biopsy System,” filed Dec. 13, 2006; andU.S. Provisional Patent Application Ser. No. 60/874,792, entitled“Biopsy Sample Storage,” filed Dec. 13, 2006. The disclosure of each ofthe above-cited U.S. patents, U.S. patent application Publications, andU.S. Provisional patent applications is incorporated by referenceherein. While several systems and methods have been made and used forobtaining a biopsy sample, it is believed that no one prior to theinventors has made or used the invention described in the appendedclaims.

BRIEF DESCRIPTION OF THE FIGURES

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentbiopsy device will be better understood from the following descriptionof certain examples taken in conjunction with the accompanying drawings,in which like reference numerals identify the same elements and inwhich:

FIG. 1 is a schematic view of an exemplary biopsy system being operatedwith a single hand and with a finger rotating a central rotation knob torotate a needle extending from a probe;

FIG. 2 is an isometric view of a biopsy device of the biopsy system ofFIG. 1;

FIG. 3 is a side cross-sectional view of the biopsy device of FIG. 2,with a probe portion separated from a holster portion;

FIG. 4 is an enlarged side cross-sectional view of the probe of FIG. 2;

FIG. 5 is an exploded view of the needle and a cutter assemblies of theprobe of FIG. 2;

FIG. 6 is an enlarged side cross-sectional view of a portion of theprobe of FIG. 2, showing a rotational assembly extending from thecentral rotation knob to the needle;

FIG. 7 is an enlarged side cross-sectional view of a portion of theprobe of FIG. 2, showing a cutter drive assembly;

FIG. 8 is a partial perspective view of a proximal portion of the probeof FIG. 2, with the upper cover removed to show a vacuum manifold systemand a cutter drive system;

FIG. 9 is a partial perspective view of a vacuum manifold system FIG. 8;

FIG. 10 is a partial perspective view showing a tissue sample holderwith a cover in dashed lines and engagement with the cutter drive systemof FIG. 8;

FIG. 11 is a perspective view of the holster of FIG. 2;

FIG. 12 is a side view of the holster of FIG. 2, with a dashed outlineto indicate a lower cover of the holster and showing a cutter drivesystem and a tissue sample holder drive system;

FIG. 13 is a side view of the view of the cutter drive system and tissuesample holder drive system FIG. 12, with an internal support structureremoved to show additional components of the cutter drive system;

FIG. 14 is a perspective view of the cutter drive system of FIG. 12;

FIG. 15 is a perspective view of an exemplary alternate tissue sampleholder drive system linking a central rotation knob a tissue sampleholder;

FIG. 16 is a perspective view of the tissue sample holder drive systemof FIG. 15, showing the tissue sample holder drive system extendingthrough a cutter drive system:

FIG. 17 is a perspective view of the drive systems of FIG. 16, with atop cover of the holster removed to show engagement of the drive systemswith the lower cover of a holster;

FIG. 18 is a partial side view of an exemplary alternate tissue sampleholder coupled with the tissue sample holder drive system of FIG. 15;

FIG. 19 is a perspective view of another exemplary holster;

FIG. 20 is a perspective view of the holster of FIG. 19, with componentsremoved to show an exemplary linking mechanism;

FIG. 21 is a perspective view of another exemplary probe coupled withanother exemplary holster, with inclined thumbwheels;

FIG. 22 is a perspective view the holster of FIG. 21;

FIG. 23 is a perspective view of another exemplary holster, with aremote thumbwheel.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

Several merely illustrative examples of biopsy devices (100) (e.g., aprobe (105) in combination with various holsters (205, 305, 705, 805,905), etc.) will be described in greater detail below. It should beunderstood, however, that components, features, functionalities, methodsof operation, contexts of use, etc. may be switched among the variousexamples of biopsy devices (100) as desired. For instance, features orcomponents of one particular holster (205, 305, 705, 805, 905) examplemay be described in detail herein, while not necessarily beingexplicitly described herein in the context of another holster (205, 305,705, 805, 905) example. This should not be read as implying that suchfeatures or components are excluded from all versions of the otherholster (205, 305, 705, 805, 905) examples or of other combinations ofprobe (105) with any other holsters (205, 305, 705, 805, 905). Instead,repetition of certain components, features, functionalities, methods ofoperation, contexts of use, etc., will be avoided for the sake ofbrevity, it being understood that such components, features,functionalities, methods of operation, contexts of use, etc. may beapplied to all biopsy devices (100) (e.g., all combinations of probe(105) with various holsters (205, 305, 705, 805, 905), etc.) unless suchcrossover is clearly inconsistent with certain versions of biopsy device(100).

I. A First Exemplary Biopsy Device

As shown in FIG. 1, an exemplary biopsy system (2) includes a biopsydevice (100) for cutting and storing tissue samples acquired from apatient and a vacuum control module (500). As shown in FIGS. 2-4, biopsydevice (100) of the present example comprises probe (105) and holster(205). Conduits (501) operatively attach to biopsy device (100) andextend between biopsy device (100) and vacuum control module (500).Biopsy device (100) of the present example is sized and balanced forsingle handed operation, and comprises a needle portion (10) extendingdistally therefrom for inserting into a patient and acquiring tissuesamples from the patient. Needle portion (10) is longitudinallyconstrained yet rotatable relative the remainder of biopsy device (100),though in other versions needle portion (10) may be non-rotatable and/oroperable to translate longitudinally relative the remainder of biopsydevice (100). As will become apparent in view of the teachings herein,some versions of biopsy device (100) may offer size reductions, improvedbalance, and enhanced single handed grasping of biopsy device (100) withan operator or surgeon's hand (1000). For instance, biopsy device (100)may be operated in a handheld fashion under ultrasonic imaging guidance.

As will be described in greater detail below, needle portion (10) isoperably connected to an exemplary central thumbwheel (60) that may beaccessed and rotated by a finger (1001) or thumb of the operator'sgrasping hand (1000). When the operator or surgeon holds biopsy device(100) within one hand, rotation of central thumbwheel (60) (e.g., with asingle finger or thumb) rotates needle portion (10) relative to theremainder of biopsy device (100) and within a desired portion of tissue.The single handed operation of the present example does not necessarilyrequire rotation and/or repositioning of any of the operator's handsduring use. Versions of biopsy device (100) may be compatible for usewith magnetic resonance, x-ray, ultrasonic, PET/PEM, and/or other typesof imaging systems. Indeed, while several examples herein relate tohandheld use of biopsy device (100), it should be understood that biopsydevice may be used in a variety of other ways. For instance, it will beappreciated in view of the disclosure herein that holster (205) may beconfigured to be mounted to a table, fixture, or other device, such asfor use in a stereotactic or X-ray setting, an MRI setting, or any othersetting. By way of example only, holster (205) may be coupled with atargeting set, such as the targeting set disclosed in U.S.Non-Provisional patent application Ser. No. 12/337,872, entitled“MULTI-ORIENTATION TARGETING SET FOR MRI BIOPSY DEVICE,” filed on Dec.18, 2008, the disclosure of which is incorporated by reference herein.Of course, it will be appreciated in view of the disclosure herein thatbiopsy device (100) may be used in a variety of other settings andcombinations.

As will be described in greater detail below, probe (105) is separablefrom its corresponding holster (205). Use of the term “holster” hereinshould not be read as requiring any portion of probe (105) to beinserted into any portion of holster (205). Indeed, in some variationsof biopsy device (100), probe (105) may simply sit on holster (205),with tissue sample holder (140) attached thereto. In some othervariations, a portion of holster (205) may be inserted into probe (100)with tissue sample holder (140) attached thereto. Furthermore, in somebiopsy devices (100), probe (105) and/or holster (205) and/or tissuesample holder (140) may be of unitary or integral construction, suchthat the components cannot be separated. Still other suitable structuraland functional relationships between probe (105), holster (205), andtissue sample holder (140) will be apparent to those of ordinary skillin the art in view of the teachings herein.

Some variations of biopsy devices (100) may include one or more sensors(not shown), in probe (105) and/or in holster (205) that is/areconfigured to detect when probe (105) is coupled with holster (205).Such sensors or other features may further be configured to permit onlycertain types of probes (105) and holsters (205) to be coupled together.In addition or in the alternative, such sensors may be configured todisable one or more functions of probe (105) and/or holster (205) untila suitable probe (105) and holster (205) are coupled together. Ofcourse, such sensors and features may be varied or omitted as desired.

By way of example only, probe (105) may be provided as a disposablecomponent, while holster (205) may be provided as a reusable component.Vacuum control module (500) is provided on a cart (not shown) in thepresent example, though like other components described herein, a cartis merely optional. Among other components described herein, afootswitch (not shown) and/or other devices may be used to provide atleast some degree of control of at least a portion of biopsy system (2).Conduits (501) provide communication of power (e.g., electrical,pneumatic, mechanical, etc.), control signals, saline, vacuum, and/orventing from vacuum control module (500) to biopsy device (100). Oneexample of a vacuum control module (500) and how it may be used isdisclosed in U.S. Pub. No. 2008/0195066, entitled “Revolving TissueSample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein. In addition, aninterface may be provided between vacuum control module (500) and biopsydevice (100). Such an interface may be provided in accordance with theteachings of U.S. Non-Provisional patent application Ser. No.12/337,814, entitled “CONTROL MODULE INTERFACE,” filed on Dec. 18, 2008,the disclosure of which is incorporated by reference herein.

It should also be understood that any of the teachings herein may bereadily incorporated with any of the teachings of U.S. Non-Provisionalpatent application Ser. No. 12/337,674, entitled “BIOPSY DEVICE WITHSLIDING CUTTER COVER,” filed on Dec. 18, 2008, the disclosure of whichis incorporated by reference herein. For instance, probe (105) mayinclude any suitable features of any probes disclosed in U.S.Non-Provisional patent application Ser. No. 12/337,674. Suitable ways inwhich teachings herein and teachings in U.S. Non-Provisional patentapplication Ser. No. 12/337,674 may be interchanged and incorporatedwith each other will be apparent to those of ordinary skill in the artin view of the teachings herein and in view of the teachings in U.S.Non-Provisional patent application Ser. No. 12/337,674.

A. Exemplary Probe

As noted above, the assembly of probe (105) and holster (205) may besized and configured for one handed operation, and may further beconfigured for one fingered rotation of central thumbwheel (60). In FIG.2, probe (105) and holster (205) are shown releasably assembled togetherand ready for the acquisition of tissue samples from a patient. A griparea (190) is provided on probe (105) and holster (205) and isconfigured to fit within and to be grasped by a single hand (1000) ofthe operator or surgeon. Grip area (190) is indicated between dashedlines on FIG. 2, and may be sized, shaped, configured, textured, coatedwith non-skid coatings, roughened, and/or altered in a myriad of ways toenhance gripping between the operator's single hand (1000) and biopsydevice (100). Of course, as noted above, biopsy device (100) need notnecessarily be held in the hand (1000) of an operator during operationof biopsy device (100).

As shown in FIGS. 2-10, probe (105) of biopsy device (100) releasablyattaches to holster (205). In FIG. 3, cross sections of unassembledprobe (105) and holster (205) are shown spaced apart with extensionlines extending between drive systems that engage together, and thereception of central thumbwheel (60) in a recess (204) in holster (205).The operative engagement of these components will be described ingreater detail below.

Probe (105) of the present example comprises needle portion (10) at adistal end, a body portion (112) at a proximal end, and centralthumbwheel (60). Needle portion (10) and body portion (112) define alongitudinal axis. Body portion (112) comprises a top cover (114), abottom cover (116), and a proximal base (113). Central thumbwheel (60)extends through an opening (115) in top cover (114) and through anopening (117) in bottom cover (116). A needle orientation indicator (65)and central thumbwheel (60) are operably attached to needle portion (10)such that manual rotation of central thumbwheel (60) by an operatorrotates both needle orientation indicator (65) and needle portion (10).The location of central thumbwheel (60) in this example is at alongitudinal position just distal to a point of balance of biopsy device(100) so that the operator can grasp biopsy device (100) at the point ofbalance, and then extend one finger distally to rotate centralthumbwheel (60), and hence, needle portion (10). Of course, centralthumbwheel (60) may be located at any other suitable position on biopsydevice (100). Furthermore, central thumbwheel (60) may be operated by anoperator's thumb instead of, e.g., the operator's index finger.

FIG. 8 shows a perspective view of a proximal portion of probe (105)with top cover (114) removed. In this view, bottom cover (116) and canbe seen rotatably supporting cutter (50), cutter rotation andtranslation mechanism (80), vacuum manifold (70), and central thumbwheel(60) at various points such as at a first saddle (124) and a secondsaddle (125). FIG. 9 shows vacuum manifold (70). Attachment of top cover(114) secures these components (50, 80, 70, 60) between top cover (114),proximal base (113), and bottom cover (116). These components (50, 80,70, 60) will be described in greater detail below.

In the present example, central thumbwheel (60) does not engage with anyportion of holster (205) when probe (105) is releasably attached toholster (205). A tissue sample holder (140) is removably attached to aproximal end of probe (105) for the reception of severed tissue samplestherein. Probe (105) is configured for manual insertion into a patient,or can be attached to a stereotactic table or other motorized device forpenetration into tissue. A level (199) such as a glass tube with abubble can be located on top of body portion (112) to indicate when thebiopsy device (100) is level. Of course, as with any other componentsdescribed herein, level (199) may be varied, substituted, supplemented,or omitted as desired.

1. Exemplary Needle

In the present example and as shown in FIG. 6, needle portion (10)extends distally from probe (105), and comprises a hollow outer cannula(12) that defines a cannula lumen (20) and a vacuum lumen (40). A blunttip (14) is located at a distal end of needle portion (10) and atransverse tissue receiving aperture (16) is located proximally from tip(14). A tissue stop (26) is provided on the proximal side of tip (14).By way of example only, cannula (12) may be introduced into a patient'sbreast by inserting cannula (12) through a separate cannula (not shown)that has a tissue piercing tip and an aperture that is configured toalign with tissue receiving aperture (16) of outer cannula (12). Inalternate embodiments, blunt tip (14) may be replaced with a tissuepiercing tip (not shown). Such a tissue piercing tip may be configuredto penetrate tissue without requiring a high amount of force, andwithout requiring an opening to be preformed in the tissue prior toinsertion of the needle portion (10). One suitable configuration for atissue piercing tip is disclosed in U.S. Pub. No. 2008/0195066, entitled“Revolving Tissue Sample Holder For Biopsy Device,” published Aug. 14,2008, the disclosure of which is incorporated by reference herein. Othersuitable configurations for a tissue piercing tip are disclosed in U.S.Non-Provisional patent application Ser. No. 12/038,359, entitled “NeedleTip for Biopsy Device,” filed Feb. 27, 2008, the disclosure of which isincorporated by reference herein. Of course, other suitableconfigurations for a blunt tip (14) or tissue piercing tip will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Transverse tissue receiving aperture (16) is configured to receivetissue drawn within, and cannula (12) has a floor or wall (30) oppositeto tissue receiving aperture (16). Wall (30) separates cannula lumen(20) and vacuum lumen (40). A plurality of openings (32) may be formedthrough wall (30) and provide fluid communication between cannula lumen(20) and vacuum lumen (40). Various ways in which vacuum, saline,atmospheric air, and/or pressurized air, etc., may be communicatedthrough openings (32) will be described in greater detail below. In someversions, wall (30) extends a substantial amount of the length of needleportion (10). In some other versions, wall (30) proximally extends justpast the proximal transverse edge of aperture (16). For instance,cannula lumen 20 may be sized and configured such that, with a cutter(50) disposed therein, a gap exists between the exterior of cutter (50)and at least a portion of the interior of cannula (12). Such a gap maydefine vacuum lumen (40) along part of the length of cannula (12),proximal to the proximal end of wall (30). Still other ways in which avacuum lumen (40) may be provided will be apparent to those of ordinaryskill in the art in view of the teachings herein.

In some versions, a plurality of external openings (not shown) areformed in cannula (12) and are in fluid communication with vacuum lumen(40). Examples of such external openings are disclosed in U.S. Pub. No.2007/0032742, entitled “Biopsy Device with Vacuum Assisted BleedingControl,” published Feb. 8, 2007, the disclosure of which isincorporated by reference herein. Of course, as with other componentsdescribed herein, such external openings are merely optional.

As noted above, needle portion (10) extends from a distal end of bodyportion (112) of probe (105), and rotates around the longitudinal axisdefined by needle portion (10). As also noted above, needle orientationindicator (65) is fixedly attached to a proximal end of cannula (12), asan integral part thereof, by overmolding. Of course, adhesives or othertechniques or structures may be used to secure needle orientationindicator (65) to cannula (12). The attachment of cannula (12) mayprovide an airtight or vacuum tight seal between the cannula (12) andneedle orientation indicator (65). Needle orientation indicator (65) ofthe present example is located at a distal end of body portion (112),away from the grasping and balance point of biopsy device (100), and ifdesired, can be rotated by an operator's free hand.

It should be understood that the components, features, configuration,and functionality of needle portion (10) described above are merelyexemplary. Needle portion (10) may be modified, supplemented, orsubstituted in any suitable way, as desired. Suitable variations ofneedle portion (10) and methods of using the same will be apparent tothose of ordinary skill in the art in view of the teachings herein.

2. Exemplary Cutter

A hollow cutter (50) is rotatably and slidably movable within cannulalumen (20) of cannula (12), and extends proximally therefrom throughbody portion (112) of probe (105) to operatively communicate with tissuesample holder (140). Cutter has a sharp distal cutting end (51) to severtissue. Cutter (50) defines a cutter lumen (52) that is configuredcommunicate fluid and tissue that is severed by cutting end (51) intotissue sample holder (140) as will be described in greater detail below.As will also be described in greater detail below, cutter (50) isconfigured to both rotate and translate longitudinally within cannulalumen (20) as cutting end (51) cuts tissue. In particular, cutter (50)is configured to sever a biopsy sample from tissue drawn into tissuereceiving aperture (16) of outer cannula (12) and to guide orcommunicate the sample through cutter lumen (52) into tissue sampleholder (140). Merely illustrative examples of such severing and proximalcommunication are described in U.S. Pat. No. 5,526,822, the disclosureof which is incorporated by reference herein, though any other suitablestructures or techniques may be used for severing and/or communicatingtissue samples within a biopsy system (2).

Cutter (50) may be subject to various treatments or configurations inorder to facilitate distal to proximal transmission of tissue samplesthrough cutter lumen (52). For instance, examples of such treatments andconfigurations are disclosed in U.S. Pub. No. 2008/0195066, entitled“Revolving Tissue Sample Holder For Biopsy Device,” published Aug. 14,2008, the disclosure of which is incorporated by reference herein. Stillother suitable variations of cutter (50) will be apparent to those ofordinary skill in the art in view of the teachings herein.

3. Exemplary Thumbwheel

As noted above, needle portion (10) and needle orientation indicator(65) may be operatively rotated using central thumbwheel (60). Thisrotational movement is around the longitudinal axis defined by needleportion (10). As shown in the exploded view of FIGS. 3-7, needle portion(10) is fixedly attached to needle orientation indicator (65), andthumbwheel (60) is spaced proximally thereto by a hollow sleeve portion(63) that attaches to needle orientation indicator (65) and centralthumbwheel (60) with a fluid tight connection. Central thumbwheel (60)has a proximal knob (61) configured with engagement teeth (62) around aperiphery thereof to enhance engagement with the operator's finger orthumb. In some versions, engagement teeth (62) can be gear teeth, or maytake a variety of other configurations. Hollow sleeve portion (63)extends distally from knob (61) and defines a hollow sleeve lumen (69).An external flange (64) extends in a raised ring around hollow sleeveportion (63) and is disposed a slot (118) in bottom cover (116) of probe(105) (FIG. 6), which permits rotation of sleeve portion (63) whilerestricting longitudinal movement of sleeve portion (63). A distal keyedend (66) of hollow sleeve portion (63) is configured to attach to bothneedle portion (10) and needle orientation indicator (65) to create afluid tight assembly (10, 60, 65) that can be rotated with thumbwheel(60).

The assembly of thumbwheel (60), needle orientation indicator (65), andneedle portion (10) brings hollow sleeve lumen (69) into fluidcommunication with cannula lumen (20) and vacuum lumen (40). Inparticular, with cutter (50) disposed in hollow sleeve lumen (69) inaddition to being disposed in cannula lumen (20), the exterior of cutter(50) and the interior of sleeve lumen (69) may define a lumen thatcorresponds with vacuum lumen (69) of cannula (12). In some versions,the fluid tight assembly (10, 60, 65) can include an adhesive (notshown) or a weld (not shown) to join needle orientation indicator (66)and needle portion (10) with thumbwheel (60). In other versions, thefluid tight assembly can include a mechanical fastening with a seal.Mechanical fastenings may include but are not limited to a snapcoupling, a bayonet coupling, a screw thread, or any other mechanicalfastening. Such fastening mechanisms may also include sealing devicessuch as o-rings, etc.

As shown in FIG. 6, thumbwheel (60) rotatably mounts within body portion(112), with thumbwheel (60) extending through opening (115) in top cover(114) and through opening (117) in bottom cover (116). As shown in FIG.3, knob (61) of thumbwheel (60) is configured to be received in a recess(204) of holster (205). The recess (204) is configured to receive knob(61) of thumbwheel (60) without any contact therebetween to provide freeand unhindered rotation of thumbwheel (60). However, as will bedescribed in greater detail below with respect to other versions,thumbwheel (60) may have a variety of other relationships withcomponents of holster (205).

Thumbwheel (60) of the present example also includes a recessed bore(67) extending into a proximal face of the knob (61), with an internaldiameter larger than the diameter of hollow sleeve lumen (69). Recessedbore (67) extends distally past knob (61) to define a shoulder (68).Recessed bore (67) is in open communication with hollow sleeve lumen(69) and is configured to receive and retain a vacuum manifold (70)within, as will be described in greater detail below.

It should be understood that the components, features, configuration,and functionality of needle thumbwheel (60) and associated componentsdescribed above are merely exemplary. Thumbwheel (60) and associatedcomponents may be modified, supplemented, or substituted in any suitableway, as desired. Suitable variations of thumbwheel (60) and associatedcomponents and methods of using the same will be apparent to those ofordinary skill in the art in view of the teachings herein.

4. Exemplary Vacuum Manifold

As shown in FIGS. 3-9, an exemplary vacuum manifold (70) is configuredto be rotatably received within recessed bore (67) of central thumbwheel(60). Vacuum manifold (70) remains stationary within body portion (112),creates a rotating airtight seal with recessed bore (67) of thumbwheel(60), and creates a dynamic fluid seal with rotating and translatingcutter (50). The dynamic fluid seal is configured to maintain fluidintegrity when cutter (50) is stationary, when cutter (50) istranslating longitudinally relative to needle manifold (80), and/or whencuter (50) rotates about the longitudinal axis. Vacuum manifold (70)also maintains a fluid seal with thumbwheel (60), even as thumbwheel(60) rotates about vacuum manifold (70).

As shown in FIGS. 5, 8, and 9, vacuum manifold (70) of the presentexample comprises a wheel shaped manifold ring (71) with a manifoldsleeve (72) extending proximally and distally through manifold ring(71). A manifold lumen (73) extends longitudinally through a center ofmanifold sleeve (72) and is configured to receive a cylindrical shapedcutter seal (75). Cutter seal (75) can be formed from an elastomericseal material and can have at least one inner surface configured to forma dynamic seal with cutter (50). An o-ring (74) can be placed withineach of the one or more grooves (76) of cutter seal (75) to form astatic seal with manifold lumen (73). O-rings (74) can also provide aninward pinching bias to ensure that cutter seal (75) maintains a dynamicseal with cutter (50). A large o-ring seal (77) is provided to form arotating seal between manifold ring (71) of vacuum manifold (70) andrecessed bore (67) of the central thumbwheel (60). An internal snap ring(78) or other type of fastening structure can retain non-moving vacuummanifold (70) within recessed bore (67) of rotatable central thumbwheel(60).

A vacuum port (79) enters a proximal side of central thumbwheel (60) andcontains a vacuum passage (55) connecting to a distal side of centralthumbwheel (60) to communicate with recessed bore (67) of the centralthumbwheel (60) for the transfer of vacuum or fluids therebetween.Vacuum cannula (79) is connected to a distal end of tube (504) to forman unbroken line of communication (fluids and/or vacuum, etc.) betweenvacuum control module (500), tube (504), vacuum passage (55), recessedbore (67), hollow sleeve lumen (69), and vacuum lumen (40) of needleportion (10). If desired, a vacuum control valve may be operativelycoupled to tube (504) to control when vacuum or fluids are appliedthereto. For instance, such a vacuum control valve may be located invacuum control module (500) or elsewhere. Suitable components andmethods relating to communication of vacuum and fluids, as may beimplemented in biopsy system (2), are described in U.S. Pub. No.2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein.

It should be understood that the components, features, configuration,and functionality of vacuum manifold (70) described above are merelyexemplary. Vacuum manifold (70) may be modified, supplemented, orsubstituted in any suitable way, as desired. Suitable variations ofvacuum manifold (70) and methods of using the same will be apparent tothose of ordinary skill in the art in view of the teachings herein.

5. Exemplary Cutter Rotation and Translation Mechanism

In the present example, and as shown in FIGS. 4, 5, 7-8, and 10, bodyportion (112) of probe (105) comprises a cutter rotation and translationmechanism (80) to rotate and translate cutter (50). Cutter rotation andtranslation mechanism (80) comprises a sleeve (82) fixed to cutter (50)with an external threaded portion (81) and a hexagonal drive portion(83). External threaded portion (81) is configured to be in threadedengagement with one or more internal threads (86) within a drive nut(87), and hexagonal drive portion (83) is configured to be in slidingand driving engagement with a hexagonal drive opening (88) within adrive member (84). Drive member (84) further comprises an external drivegear (85) configured to be rotated by an intermediate driven gear (238)of holster (205) to drive cutter rotation and translation mechanism(80).

As shown in FIG. 7, drive nut (87) is engaged with external threadedportion (81) of sleeve (82), and drive member (84) is slidably receivedon hexagonal drive portion (83) of sleeve (82). Drive nut (87) issecurably received within base (113). Drive member (84) is rotatablyreceived in a transverse slot (119) between top cover (114) and base(113), with a portion of external drive gear (85) being exposed throughtransverse slot (119). External drive gear (85) is configured todrivably engage with an intermediate driven gear (238) of holster (205)when probe (105) is coupled with holster (205). As intermediate drivengear (238) rotates in holster (205), the driving engagement rotatesexternal drive gear (85), which rotates hexagonal drive portion (83) ofsleeve (82), thereby rotating cutter (50). As cutter (50) and sleeve(82) are rotated by drive member (84), the threaded engagement betweenfixed drive nut (87) and external threaded portion (81) of the sleeve(82) translates cutter (50) and sleeve (82) longitudinally. Depending onthe direction of rotation of drive member (84), cutter (50) and sleeve(82) translate either proximally or distally along the longitudinalaxis. Thus, cutter rotation and translation mechanism (80)simultaneously rotates and translates cutter (50) in response torotation of drive member (84).

It will be appreciated in view of the teachings herein that cutterrotation and translation mechanism (80) described above is merelyexemplary, and that translation and/or rotation of cutter (50) mayalternatively be provided in various other ways. For instance, probe(105) may include a motor or other device, such that probe (105) lacksexposed external drive gear (85). It should also be understood thatcutter rotation and translation mechanism (80) may be constructed andused in accordance with any of the teachings of U.S. Pub. No.2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein. Alternatively, any suitable structureother than exposed external drive gear (85) e.g., a rack, etc. may beused to receive communication of motion or energy from some othercomponent, in order to rotate and/or translate cutter (50). Furthermore,cutter rotation and translation mechanism (120) may be configured suchthat more than one external drive gear (85) is present (e.g., oneexternal drive gear (85) for providing translation motion, and anotherexternal drive gear (85) for providing rotation motion, etc.). In othermerely illustrative alternatives, translation and/or rotation of cutter(50) may be performed at least in part by pneumatic actuators not shown,pneumatic motors not shown, or a variety of other components.Furthermore, it will be appreciated that pneumatic components may becombined with other mechanical components and/or electro-mechanicalcomponents in order to translate and/or rotate cutter (50). Still othersuitable variations of cutter rotation and translation mechanism (80)and methods of using the same will be apparent to those of ordinaryskill in the art in view of the teachings herein.

6. Exemplary Tissue Sample Holder and Manifold

As shown in FIGS. 3-4 and 10, proximal base (113) further comprises alight pipe (188) mounted thereto. Light pipe (188) is constructed from atransparent or translucent material and is configured to be illuminatedfrom within by a light source (not shown). Light pipe (188) is locatedadjacent to a tissue sample holder (140) and can conduct light thereto.An axial vacuum tube (502) is coupled with light pipe (188) and isthereby placed in fluid communication with tissue sample holder (140) bya passage (189) formed through light pipe (188). Of course, light pipe(188) need not be transparent or translucent. By way of example only,light pipe (188) may instead be formed of an opaque plastic or any othermaterial(s) having any suitable properties.

Proximal base (113) further defines tissue sample passage (54), throughwhich the proximal end of cutter (50) is disposed (FIG. 4). A seal (56)is provided at the distal interface of cutter (50) and tissue samplepassage (54), to prevent escape of vacuum or fluid between the outersurface of cutter (50) and the tissue sample passage (54) whilepermitting cutter (50) to rotate and translate relative to seal (56).Tissue sample passage (54) is sized such that, as cutter (50) translatesduring use of biopsy device (100), the proximal end of cutter (50)remains within tissue sample passage (54) and seal (56) maintains adynamic seal therewith. Tissue sample passage (54) is thus in sealedfluid communication with cutter lumen (52). Of course, any othersuitable structures or configurations may be used. In the presentexample, tissue sample passage (54) extends proximally from seal (56) toa proximal end of proximal base (113), and is also configured to receiveand pass tissue samples emerging from the proximal end of cutter (50).Tissue samples emerge from tissue sample passage (54) and exit intotissue sample holder (140).

As shown in FIGS. 2-4, 8, and 10, tissue sample holder (140) of thepresent example is located at a proximal end of probe (105) and isconfigured to receive a plurality of severed tissue samples within asthey exit from tissue sample passage (54). Tissue sample holder (140) isfurther configured to store each sample individually, and the storedsamples can be removed from the exemplary tissue sample holder (140) forstudy. Tissue sample holder (140) of the present example comprises arotatable manifold (144). Manifold (144) is configured to removablyattach to and rotate around a longitudinal shaft (147) (FIGS. 3 and 4)to successively align tissue sample chambers (146) with tissue samplepassage (54) for the reception of tissue samples therefrom, as will bedescribed in greater detail below. Manifold (144) has a paddlewheel likeconfiguration, and has a plurality of outwardly extending paddles (notshown). The paddles are radially spaced about manifold (144), and extendlongitudinally.

Manifold (144) further comprises a plurality of inner openings (notshown) and a corresponding set of rear openings (145). The inneropenings are radially spaced about the distal face of manifold (144),facing light pipe (188), and extend longitudinally through a portion ofmanifold (144). Each inner opening is discrete from the other inneropenings, and communicates with a respective internal passage (144) thatalso communicates with an associated rear opening (145). The inneropenings of manifold (144) are positioned to successively align withpassage (189) formed through light pipe (188). Given this, and thecommunication of each inner passage of manifold (144) with acorresponding rear opening (145), those of ordinary skill in the artwill recognize in view of the teachings herein that rear openings (145)may be successively placed in fluid communication with tube (502) asmanifold (144) is rotated by shaft (147). Furthermore, as each inneropening of manifold (144) is indexed to passage (189), a correspondingtissue sample chamber (166) (that corresponds with the associated rearopening (145)) is also concomitantly indexed to tissue sample passage(54).

As shown in FIG. 10, one or more tissue sample trays (160) areconfigured to removably mount over the plurality of outwardly extendingpaddles of manifold (144). Tissue sample trays (160) define a pluralityof tissue sample chambers (166) that correspond with gaps definedbetween the paddles of manifold (144). The outwardly extending paddlesof manifold (144) are thus covered by tissue sample trays (160). Tissuesample trays (160) are configured to receive a severed tissue samplewithin each tissue sample chamber (166), and are further configured forremoval from manifold (144) so that one or more trays (160) of tissuesamples may be sent to pathology. Replacement tissue sample trays (160)may be provided to replace trays (160) removed during a procedure.Tissue sample trays (160) may include markings or other indicia.

Tissue sample trays (160) are configured and positioned to provide fluidcommunication from rear openings (145) to tissue sample passage (54). Inparticular, such fluid communication may be provided through whichevertissue sample chamber (166) is indexed to tissue sample passage (54). Itwill therefore be appreciated in view of the teachings herein thattissue sample passage (54) (and hence, cutter lumen (52)) may be placedin fluid communication with tube (502) via whichever tissue samplechamber (166) and associated rear opening (145) is indexed to tissuesample passage (54). By way of example only, a vacuum may becommunicated through tube (502) to draw a severed tissue sample throughcutter lumen (52) and into whichever tissue sample chamber (166) isindexed to tissue sample passage (54).

Manifold (144) of the present example is thus configured to rotaterelative to proximal base (113), to align one tissue sample chamber(166) with tissue sample passage (54). Vacuum may be communicated totissue sample holder (140) from tube (502). When a tissue sample hasbeen severed by cutting end (51) of cutter (50) and a vacuum is appliedto tissue sample holder (140) by tube (502), the severed tissue sampleis drawn down cutter lumen (52), into the tissue sample passage (54),and is deposited into the aligned tissue sample chamber (166).

Tissue sample holder (140) further comprises a removable cup (141) thatsurrounds a rotatable manifold (144). Removable cup (141) is releasablyattached to base (113) via a coupling such as a bayonet coupling (134).An O-ring or cup seal (136) can be placed between base (113) and theremovable cup (141) to create a vacuum or fluid seal therewith. Rotationof removable cup (141) disengages bayonet coupling (134), allowing cup(141) to be removed (not shown). Removal of cup (141) exposes manifold(144) and tissue sample trays (160) (FIG. 10). Cup (141) is also formedof a transparent material in the present example, enabling the user tovisually inspect tissue samples in tissue sample holder (140) whiletissue sample holder (140) is still coupled with proximal base (113).Light pipe (188) can provide illumination for the tissue sample holder(140). Of course, cup (141) may alternatively have any other suitableproperties.

As noted above, manifold (144) is configured to removably attach to andbe rotated by shaft (147). As shown in FIGS. 3-4, shaft (147) isrotatably received within base (113) and rotates about an axis parallelto the longitudinal axis defined by cutter lumen (52). The distal end ofshaft (147) has a unitary gear (170), which is configured to drive orrotate manifold (144). Shaft (147) may rotate manifold (144) by a keyedengagement such as a blade or woodruff key extending from a roundportion of the shaft (147). As will be described in greater detailbelow, gear (170) is configured to mesh with a drive gear (251) ofholster (205), such that gear (251) may be used to impart rotation togear (170). Such rotation may be used to selectively (e.g.,consecutively) align tissue sample chambers (166) with tissue samplepassage (54), to successively collect a discrete tissue sample in eachchamber (166) during use of biopsy device (100).

As shown in FIG. 10, tissue sample holder (140) of the present examplehas a longitudinal passage (158) formed through manifold (144). Passage(158) of this example is a hollow rectangular tube structure extendinglongitudinally, completely through manifold (144), and is offset frombut parallel with the central axis defined by manifold (144). Likechambers (166), passage (158) is configured to be selectively alignedwith tissue sample passage (54) and to form a continuous passagewaythrough tissue sample passage (54), and through cutter lumen (52).Passage (158) of the present example is configured to permit instrumentsand/or liquids, other materials, etc., to be passed through manifold(144) and through tissue sample passage (54). For instance, passage(158) may be used to insert an instrument for deploying one or moremarkers at a biopsy site, via tissue sample passage (54) and via cutterlumen (52), out through aperture (16). A merely exemplary marker applierthat may be inserted through passage (158) may include the MAMMOMARKbiopsy site marker applier, by Ethicon Endo-Surgery, Inc. of Cincinnati,Ohio. Other suitable marker applier devices that may be inserted throughpassage (158) may include any of those described in U.S. Pat. No.7,047,063; U.S. Pat. No. 6,996,433; U.S. Pat. No. 6,993,375; or U.S.Pub. No. 2005/0228311, the disclosure of each of which is incorporatedby reference herein. Any of such appliers, including variations of thesame, may be introduced through passage (158) to deploy one or moremarkers at a biopsy site, via aperture (16), while needle portion (10)remains inserted in a patient e.g., shortly after biopsy samples areextracted from the patient, etc. Such marker deployment may beaccomplished even while tissue samples reside within tissue sampleholder (140), secured to biopsy probe (105). Alternatively, such markerappliers may be inserted directly into tissue sample passage (54) withtissue sample holder (140) being removed from biopsy probe (105).

It should be understood that tissue sample holder (140) and itsassociated components may be constructed and used in accordance with anyof the teachings of U.S. Pub. No. 2008/0195066, entitled “RevolvingTissue Sample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein. By way ofexample only, probe (105) may include a parking pawl (not shown) toselectively engage gear (170) to prevent rotation of manifold (144) whenprobe (105) is decoupled from holster (205). As another variation,tissue sample holder (140) may be constructed and used in accordancewith any of the teachings of U.S. Non-Provisional patent applicationSer. No. 12/337,911, entitled “BIOPSY DEVICE WITH DISCRETE TISSUECHAMBERS,” filed on Dec. 18, 2008, the disclosure of which isincorporated by reference herein. Still other suitable variations oftissue sample holder (140), its associated components, and methods ofusing the same will be apparent to those of ordinary skill in the art inview of the teachings herein.

B. Exemplary Holster

As shown in FIGS. 3 and 11, holster (205) of the present examplecomprises a body (212) having a top housing member (207), through whicha portion of an intermediate driven gear (238) is exposed, and a bottomhousing member (206). Recess (204) is provided in top housing member(207) to receive thumbwheel (60) within without interference or contacttherewith when probe (105) is coupled with holster (205). A plurality ofhook members (214) extend from top housing member (207) for selectivelysecuring probe (105) to holster (205), though other structures ortechniques may be used. Holster (205) of this embodiment furthercomprises a cutter drive mechanism (210) and a tissue holder rotationmechanism (240). Each of these merely exemplary components will bedescribed in greater detail below. Holster (205) of the present exampleis configured to be coupled with a biopsy probe (105), such as biopsyprobe (105) described above, to provide a biopsy device (100). Inaddition, holster (205) is configured to be handheld, such that biopsydevice (105) may be manipulated and operated by a single hand of a user(e.g., using ultrasound guidance, etc.). However, it will be appreciatedin view of the disclosure herein that holster (205) may be used in avariety of other settings and combinations.

1. Exemplary Cutter Drive Mechanism

As shown in FIGS. 3 and 11-14, cutter drive mechanism (210) of thepresent example comprises a drive cable (215) having an inner wire cable(217) rotatably encased in a sheath (219). Drive cable (215) extendsbetween holster (205) and the vacuum control module (500). A motor (530)is located within vacuum control module (500) and is operably coupled toa proximal end of the drive cable (215) (FIG. 1) to rotate inner wirecable (217) within the non-rotating sheath (219). By way of exampleonly, motor (530) may be provided in accordance with, and incorporatedwith vacuum control module (500) in accordance with, the teachings ofU.S. Non-Provisional patent application Ser. No. 12/337,814, entitled“CONTROL MODULE INTERFACE,” filed on Dec. 18, 2008, the disclosure ofwhich is incorporated by reference herein.

Drive cable (215) enters into bottom housing member (206) through astrain relief (209). A distal end connector (208) is crimped or attachedto a distal end of non-rotating sheath (219) for attachment to theholster (205). End connector (208) is captured between bottom housingmember (206) and a bottom portion of a middle plate (221) of holster(205) to secure drive cable (215) to holster (205). Middle plate (221)is an intermediate bearing plate that mounts into bottom housing member(206) to securely capture the distal end of non-rotating sheath (219)and will be described in more detail below. A distal end of inner wirecable (217) is attached to a cable drive gear (225) by a shock assembly(228). Shock assembly (228) is an energy absorber configured to reducerotational drive shocks between inner wire cable (217) and cable drivegear (225). Shock assembly (228) comprises a flex end coupling (222)fixedly attached to the inner wire cable (217), and a holster endcoupling (224) fixedly attached to the cable drive gear (225). Gapsbetween flex end coupling (222) and holster end coupling (224) arefilled with an elastomeric shock absorber (223) that is captured betweenflex end coupling (222) and holster end coupling (224). Shock absorber(223) is configured to transmit rotation from inner wire cable (217) tocable drive gear (225) and is also configured to accommodatemisalignment between inner wire cable (217) and cable drive gear (225).Shock absorber (223) may also smooth velocity or rotational differencesbetween inner wire cable (217) and cable drive gear (225). Of course, aswith other components described herein, shock assembly (228) is merelyoptional. By way of example only, inner wire cable (217) may be directlyconnected to cable drive gear (225) if desired.

Cable drive gear (225) is rotatably secured between drive gear saddles(226) extending downward from a distal end of middle plate (221); whileopposing drive gear saddles (not shown) extend upward from an inside ofbottom housing member (206) such that cable drive gear (225) issupported therebetween. Rotation of inner wire cable (217) rotates cabledrive gear (225) in saddles (226).

On a top of middle plate (221), a pair of driven gear saddles (227)extend upwardly from the distal end of middle plate (221) in directopposition to saddles (226) extending downwardly from middle plate(221). Driven gear saddles (227) rotatably support an idler driven gear(230) therebetween, and are positioned to align idler driven gear (230)directly above cable drive gear (225) and in toothed driving engagementtherewith. The driving engagement of idler driven gear (230) with cabledrive gear (225) enables idler driven gear (230) to rotate in responseto rotation of inner wire cable (217) of drive cable (215).

An idler shaft (232) extends proximally from a center of idler drivengear (230), and has an idler drive gear (234) attached to idler shaft(232) at a location proximally spaced from the driven gear (230). Bothidler gear (234) and idler shaft (232) are rotatably received in anidler saddle block (236) extending upwardly from a proximal end ofmiddle plate (221). Idler saddle block (236) is configured to rotatablysupport inline idler shaft (232) and idler gear (234), as well as anintermediate driven gear (238) located above idler gear (234). As shown,idler gear (234) is in driving engagement with intermediate driven gear(238) and is supported above in a position where a portion of theintermediate driven gear (238) is exposed through an opening (211) (FIG.11) within top housing member (207).

When top housing member (207) is attached to bottom housing member(206), idler shaft (232), idler gear (234), and intermediate driven gear(238) are rotatably captured between saddle block features extendingdownward from top housing member (207) to engage with driven gearsaddles (227) and idler saddle block (236). With appropriate materialselection, the rotating elements of cutter drive mechanism (210) such asidler shaft (232) may be run within saddles (226, 227, 236, etc.). Byway of example only, bearings may be provided to support the rotatingelements and to reduce friction. These bearings may be of anyconventional bearing construction such as ball bearings, rollerbearings, or sleeve bearings, and can be provided with or withoutlubricants. If needed, seals such as oil or grease seals may be providedfor use with the bearings to prevent migration of lubricants to unwantedareas. For instance, sleeve bearings may be molded from slick orlubricious materials such as nylons, acetals (delrin), Teflonimpregnated polymers, or any other moldable sleeve bearing materials.

As shown in FIGS. 13-14, cable drive gear (225) may be supported oneither side by a first bearing (270) and a second bearing (271). Thirdbearing (272) and fourth bearing (273) are placed to support idlerdriven gear (230) on either side; and fifth bearing (274) is placed tosupport a center of the idler shaft (232). Idler drive gear (234) issupported by sixth bearing (275) and seventh bearing (276); andintermediate driven gear (238) can be supported by eighth bearing (277)and ninth bearing (278).

When biopsy probe (105) attaches to holster (205), external drive gear(85) extending from biopsy probe (105) is brought into drivingengagement with intermediate driven gear (238), and cutter drivemechanism (210) is thus operably engaged with cutter rotation andtranslation mechanism (80) of the biopsy probe (105). It will thereforebe appreciated by those of ordinary skill in the art that rotation ofinner wire cable (217) of drive cable (215) causes simultaneous rotationand translation of cutter (50) in this example.

Of course, cutter drive mechanism (210) may take a variety of otherforms, and may have any number of alternative features, components,configurations, and principles of operation. It should therefore beunderstood that the above described cutter drive mechanism (210) ismerely one example. By way of example only, a motor may be provided inholster (205) for driving gears (238, 85), eliminating drive cable(215). As another merely illustrative example, cutter drive mechanism(210) may be configured in accordance with the teachings of U.S. Pub.No. 2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein. Other suitable features, components,configurations, and principles of operation of a cutter drive mechanism(210) will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

2. Exemplary Idler Shaft Encoder

In the present example, an encoder assembly (240) mounts to a proximalend of idler shaft (232) and is operably connected to motor (530) viawiring (280) extending between holster (205) and vacuum control module(500). Encoder assembly (240) is secured in holster (205) between tophousing member (207) and bottom housing member (206). Wiring (280)extends to a connector (514), to which another wire (254) is connectedas described below. An encoder cable (515) extends from connector (514)to vacuum control module (500). Encoder assembly (240) of this examplemeasures rotational movement of idler shaft (232) and may be used to“count” revolutions of idler gear shaft (232), which may be used (e.g.,with the thread ratio of threads (81, 86)) to indirectly measurerotation and translation (linear travel) of cutter (50) within probe(105). Gears (225, 230, 234, 238) of the present example are configuredto provide a 1.5:1 rotational ratio between wire cable (217, 317) ofdrive cable (215, 315) and idler shaft (232); and a 1:1 rotational ratiobetween wire cable (217, 317) of drive cable (215, 315) and theintermediate driven gear (238). Encoder assembly (240) “counts” 1.5revolutions at idler shaft (232) for every rotation of wire cable (217,317) of drive cable (215, 315). The rotational and positionalinformation from encoder assembly (240) may be used to determine ifidler shaft (332) is rotating, may measure idler shaft (332) speed, maymeasure rotational position of shaft (332), and/or may be used forhoming routines to determine the location of cutter (50) (e.g.,longitudinal position) within biopsy device (101). Alternatively, anyother suitable use may be made of encoder assembly (240), to the extentthat an encoder assembly (240) is included at all.

Homing routines may engage motor (530) to move cutter (50) to a proximalmost or a distal most position. Cutter (50) may contact a stop at theproximal most or the distal most position that prevents further movementof cutter (50). With cutter (50) stopped, encoder assembly 240 stopsrotating, which informs motor control system (540) that a homingposition has been reached, and a counter within motor control system(540) is set to zero. With the counter at set at zero at the “home”position, each revolution of idler shaft (332) may be used to calculatelinear and rotational positioning of cutter (50) within biopsy probe(105). By way of example only, each revolution of inner wire cable (217,317) of drive cable (215, 315) may results in approximately 0.00012inches of linear translation of cutter (50), and each revolution ofinner wire cable (217, 317) rotates idler shaft (232) an amount of 1.5revolutions. Of course, any other suitable ratios may be used.

3. Exemplary Tissue Holder Rotation Mechanism

As described above, and as shown in FIGS. 3-4 and 10, tissue sampleholder (140) on probe (105) contains manifold (144) which is aligned androtated during the acquisition of consecutive tissue samples. Inparticular, manifold (144) is rotated to successively index tissuecollection chambers (166) to tissue sample passage (54), which isaligned with cutter lumen (52). The rotation and alignment of themanifold (144) may ensure that each severed tissue sample is storedseparately in an empty tissue sample chamber (166). In the presentexample, a tissue holder rotation mechanism (242) is provided withinholster (205) to engage with holder gear (170), and to rotate manifold(144) when biopsy probe (105) is attached to holster (205).

Tissue holder rotation mechanism (242) of the present example comprisesa piezoelectric motor (250) mounted in holster (205). Piezoelectricmotor (250) is a piezo effect stepper motor that is slidably received inbottom housing member (206) of holster (205) and is constrained thereinby top housing member (207). Piezoelectric motor (250) may be magneticresonance compatable and may be configured to operate in the magneticresonance environment. One suitable motor for piezoelectric motor (250)is a Shinsei piezoelectric motor USR30-B4 or a non-magnetic Shinseipiezoelectric motor such as the USR30-S4N, both available from ShinseiCorporation, 2-1-8 Kasuya Setagaya-ku Tokyo 157-0063 Japan.Piezoelectric motor (250) comprises rotatable shaft (252) extendingproximally from motor (250). A holder drive gear (251) is attached to aproximally extending portion of shaft (252) to extend proximally throughan opening (279) (FIG. 3) in a proximal end of top housing member (207).A portion of holder drive gear (251) is exposed by opening (279) and isconfigured to engage with the exposed holder gear (170) on the undersideof probe (105) when probe (105) is coupled with holster (205). Whenprobe (105) is coupled with holster (205) to engage holder drive gear(251) with the holder gear (170) and piezoelectric motor (250) isactuated, manifold (144) is rotated within tissue sample holder (140).

An encoder (253) mounts to a distally extending portion of shaft (252)and is used to sense rotational motion or rotational positioning ofpiezoelectric motor (250), and to indirectly measure movement ofmanifold (144) within the tissue sample holder (140). A cable or wire(254) extends from encoder (253) to connector (514), to encoder cable(515), and to vacuum control module (500). As noted above, encoderassembly (240) and the idler shaft (232) are also electrically coupledto vacuum control module (500) via wire (280) connecting to connector(514) and encoder cable (515). Encoder cable (515) may extend alongsheath (219) and may be secured thereto or therein. Alternatively,encoder cable (515) may be provided as separate from sheath (219).Further still, encoder cable (515) and wires (280, 254) may beeliminated, and electronic communication may be provided wirelessly. Asyet another merely illustrative variation, cable (515) and wires (280,254) may be attached or integrated circumferentially with mechanicalcable (215). Of course, encoders (240, 253) may also be omittedaltogether if desired.

It should be understood that tissue holder rotation mechanism (242) maybe varied in a number of ways. By way of example only, tissue holderrotation mechanism (242) may be modified in accordance with theteachings of U.S. Pub. No. 2008/0195066, entitled “Revolving TissueSample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein. As anothermerely illustrative variation, tissue holder rotation mechanism (242)may be driven by cable (217) or another drive cable that is driven by aremote motor. As yet another merely illustrative variation, tissueholder rotation mechanism (242) may be omitted altogether. For instance,tissue sample holder (140) may be manually rotatable or non-rotatable,if desired. As yet another merely illustrative variation, biopsy probe(100) may be configured in accordance with U.S. Non-Provisional patentapplication Ser. No. 12/337,874, entitled “MECHANICAL TISSUE SAMPLEHOLDER INDEXING DEVICE,” filed on Dec. 18, 2008, the disclosure of whichis incorporated by reference herein, and which includes several examplesof how manual rotation of tissue sample holder (140) may be provided.Still other suitable features, components, configurations, andprinciples of operation of a tissue holder rotation mechanism (242) willbe apparent to those of ordinary skill in the art in view of theteachings herein.

C. Exemplary Use

In one example of operation, as biopsy probe (105) is attached ontoholster (205), such that holder gear (170) on biopsy probe (105) isbrought into engagement with holder drive gear (251). A parking pawl(not shown) has held manifold (144) in a first position with a firstpredetermined chamber (166) aligned with tissue sample passage (54) forthe reception of the first biopsy tissue sample within. Once gears (170,251) are engaged and parking pawl (182) is disengaged, the rotationalpositioning of manifold (144) is controlled by piezo motor (250).Software or control logic is used to automatically reposition manifold(144) after each tissue sample is received within an empty chamber (166)to move a fresh empty chamber (166) into alignment with the tissuesample passage (54) for the receipt of the next tissue sample therein.Piezo motor (250) may also be commanded to “present” a captured tissuesample to the operator before indexing the next empty chamber to tissuesample passage (54). Examples of such tissue sample presentation aredisclosed in U.S. Pub. No. 2008/0195066, entitled “Revolving TissueSample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein.

For acquisition of a tissue sample, biopsy device (100) is grasped in asingle hand (1000) of the operator or surgeon by grasping biopsy device(100) from the top or in any other suitable fashion. For instance, thefingers of the surgeon's hand (1000) may be curled under the holster(205) with the surgeon's thumb on the top of probe (105). With biopsydevice held in the surgeon's hand (1000) in this manner, the thumb ofthe grasping hand may be lifted from biopsy probe (105) and moved toreach out and access thumbwheel (60) protruding from the top of probe(105). Lateral movement of the surgeon's thumb (of the grasping hand)may rotate thumbwheel (60) and needle portion (10) to orient aperture(16) at a desired angular orientation about the axis defined by cannula(12). Alternately, biopsy device (100) may be mounted to a targetingset, such as any of the devices disclosed in U.S. Non-Provisional patentapplication Ser. No. 12/337,872, entitled “MUTLI-ORIENTATION TARGETINGSET FOR MRI BIOPSY DEVICE,” filed on Dec. 18, 2008, the disclosure ofwhich is incorporated by reference herein.

II. Second Exemplary Holster

As shown in FIGS. 15-17, another exemplary biopsy device (101) comprisesthe above described probe (105) in combination with a different holster(305). The assembly thereof is sized and configured for one handedoperation, and is configured for one fingered rotation of the centralthumbwheel (60). In FIGS. 15-16, probe (105) and holster (305) are shownreleasably assembled together and ready for the acquisition of tissuesamples from a patient. Unlike the previously described biopsy device(100), when probe (105) is assembled with holster (305), centralthumbwheel (60) of biopsy probe (105) is rotatably coupled to arotatable manifold such as rotatable manifold (144) (within tissuesample holder (140)) by holster (305). The assembly of probe (105) andholster (305) is thus such that rotation of central thumbwheel (60)rotates the rotatable manifold (144). Disassembly of probe (105) fromholster (305) disengages central thumbwheel (60) from rotatable manifold(144).

The rotational linking of central thumbwheel (60) and rotatable manifold(144) ensures that tissue samples are stored within rotating manifold(144) at the same rotational angle as tissue receiving aperture (16) ofthe needle portion (10). Alternatively, the rotational linking mayprovide some other direct correlation between the rotational angle ofaperture (16) and manifold (144). As noted above, and as will bedescribed in greater detail below, central thumbwheel (60) and rotatablemanifold (144) are not linked together within probe (105) in thisexample, for the linking between thumbwheel (60) and manifold (144)occurs within holster (305) when probe (105) is coupled with holster(305).

As shown in FIGS. 15-17, holster (305) of this example further comprisesan exemplary tissue holder rotational mechanism (340) and an exemplarycable driven cutter drive mechanism (310). Holster 305 comprises a tophousing member (307) and a bottom housing member (306). The externaldimensions of holster (305) may be identical to external dimensions andconfigurations as described for the above holster (205), and holsters(205, 305) may have the same grip area 190 as illustrated in FIG. 2. Tophousing member (307) has an opening (311) therein exposing a portion ofan intermediate driven gear (338) of cable driven cutter drive mechanism(310). A recess (304) is provided in top housing member (307) to receivecentral thumbwheel (60) of probe (105), and a thumbwheel drive slot(303) extends through recess (304) to expose a thumbwheel gear (350) oftissue holder rotational mechanism (340). As will be described ingreater detail below, thumbwheel gear (350) is configured to rotatablyengage with teeth (61) of central thumbwheel (60); and intermediatedriven gear (338) is configured to rotatably engage with gear (85)extending from probe (105) when probe (105) is coupled with holster(305).

A. Exemplary Alternate Tissue Holder Rotation Mechanism

FIG. 15 shows probe (105) attached to holster (305) to show theexemplary tissue holder rotational mechanism (340). In this view, tophousing member (307) of holster (305) is shown attached to probe (105),and bottom housing member (306) is shown as an outline to show elementswithin. For clarity in showing elements of the exemplary tissue holderrotational mechanism (340), elements of the exemplary cable drivencutter drive mechanism (310) are removed from this view with theexception of a drive cable (315) and certain rotatable elementsassociated therewith.

Central thumbwheel (60) of probe (105) is shown rotatably linked tomanifold (144) located within tissue sample holder (140) via gear (170).This rotational linking is accomplished by engaging central thumbwheel(60) and manifold (144) with the exemplary tissue holder rotationalmechanism (340) located within holster 305.

As shown in FIG. 15, thumbwheel gear (350) of tissue holder rotationalmechanism (340) has plurality of teeth around a periphery thereof, andthumbwheel gear (350) extends through thumbwheel drive slot (303) inrecess (304) of top housing member (307). When probe (105) is attachedto holster (305) as shown, the plurality of teeth around a periphery ofthumbwheel gear (350) are rotatably engaged with teeth (61) ofthumbwheel (60). Rotation of thumbwheel (60) thus causes rotation ofthumbwheel gear (350).

Tissue holder rotational mechanism (340) of the present example furthercomprises a rotary shaft (353) that extends proximally through a centerof thumbwheel gear (350) and rotates with thumbwheel gear (350). Atakeoff gear (355) is attached to the proximal end of shaft (353) androtates with shaft (353). Shaft (353) and gears (350, 355) are supportedby a distal bearing (382) mounted in a first rotary saddle (380); and bya proximal bearing (383) mounted in a secondary rotary saddle (381).Rotary saddles (380, 381) are configured to extend downward from thehousing member (307). An intermediate gear (356) is engaged with thetakeoff gear (355) and rotates therewith. Intermediate gear (356) isalso rotatably engaged with a distal drive gear (357), such thatrotation of the takeoff gear (355) rotates intermediate gear (356) anddistal drive gear (357). A short drive shaft (359) extendslongitudinally and proximally from distal drive gear (357) and isattached to a proximal takeoff gear (358). Proximal takeoff gear (358)is located below a proximal opening (279) at a proximal end of tophousing member (307) and is accessible through opening (279). Thus,working through the gear train of the exemplary tissue holder rotationalmechanism (340), rotation of thumbwheel gear (350) through slot (303)ultimately rotates proximal takeoff gear (358), which is exposed inproximal opening (279) at the proximal end of holster (350).

When probe (105) is attached to holster (305), thumbwheel (60) of probe(105) engages with thumbwheel gear (350) of holster (305), and theproximal takeoff gear (358) of holster (305) engages with holder gear(170) of probe (105). As shown in FIGS. 3-4 and 10, and as describedabove, holder gear 170 is directly coupled with manifold (144) withintissue sample holder (140). Thus, the attachment of probe (105) toholster (305) rotatingly couples thumbwheel (60) to manifold (144) viatissue holder rotational mechanism (340), and rotation of thumbwheel(60) thereby rotates manifold (144).

A gear drive ratio exists between the rotational input from thumbwheel(60) and the rotational output at manifold (144). Gear ratios within theholder rotational mechanism (340) directly affect the gear drive ratio.The gear drive ratio (input to output) can be configured by alteringgear ratios of the holder rotational mechanism (340) such that a givendegree of rotation of thumbwheel (60) produces a certain degree ofrotation at manifold (144). Such a ratio may be 1:1, by way of exampleonly. In alternate embodiments, the gear ratios can be altered so that adegree of rotation at thumbwheel (60) produces more than a degree ofrotation at manifold (144), or a degree of rotation at thumbwheel (60)produces less than a degree of rotation at the manifold (144). Suitableratios will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

It should also be understood that rotation of manifold (144) may beprovided in predefined increments, such as to provide some degree ofself-alignment of each tissue sample chamber (166) with tissue samplepassage (54). For instance, accurate indexing positions can be achievedusing a spring loaded detent (not shown), using a self-aligningmechanism between a housing component of tissue sample holder (140) andlight pipe (188) or some other component of probe (105); or using anyother suitable components, features, configurations, or techniques.Tissue holder rotation mechanism (340) may also provide audible, visual,and/or tactile feedback to indicate successful alignment of a tissuesample chamber (166) with tissue sample passage (54). Still othersuitable features, components, configurations, functionalities, andoperational methods of holder rotation mechanism (340) will be apparentto those of ordinary skill in the art in view of the teachings herein.

B. Exemplary Cable Driven Cutter Drive Mechanism

In FIG. 16, all of the drive elements of a cable driven cutter drivemechanism (310) are shown in combination with tissue holder rotationalmechanism (340). As will be described in detail below, portions oftissue holder rotational mechanism (340), such as a rotary shaft (353),are coaxially nested within a hollow idler shaft (332) of cable drivencutter drive mechanism (310). Shafts (353, 332) rotate independentlyfrom each other, and can rotate in the same time and/or oppositerotational directions.

Cutter drive mechanism (310) of the present example is substantiallysimilar to cutter drive mechanism (210) of holster (205). For instance,cutter drive mechanism (310) comprises a drive cable (310) having aninner wire cable (317) and a sheath (319) and which enters through abottom strain relief. These components respectively correlate with drivecable (215), wire cable (217), sheath (219), and strain relief (209) ofholster (205). Cutter drive mechanism (310) further comprises a distalend connector (308); and a shock assembly (328) comprising a flex endcoupling (322), a holster end coupling (324) fixedly attached to a cabledrive gear (325), and an elastomeric shock absorber (323) that iscaptured between flex end coupling (322) and holster end coupling (324).These components respectively correlate with distal end connector (208,308), shock assembly (228, 328), couplings (222, 224), cable drive gear(225), and shock absorber (223) of holster (205) as described above.Cutter drive mechanism (310) further comprises bearings (326, 327, 372,373, 374 375 376, 377, 378), an idler driven gear (330), a hollow idlershaft (332), an idler drive gear (334), and an intermediate driven gear(338). These components respectively correlate with bearings (226, 227,272, 273, 274 275 276, 277, 278), idler driven gear (230), hollow idlershaft (232), idler drive gear (234), and intermediate driven gear (238)of holster (205).

As shown, a portion of intermediate driven gear (338) extends through aslot (311) in top housing member (307) and is rotatably engaged withgear 85 of probe (105). Gear (85) is engaged with cutter rotation andtranslation mechanism (80) of probe (105) to simultaneously rotate andtranslate cutter (50) as described above. It will therefore beappreciated that rotation of cable (317) in the present example willcause simultaneous rotation and translation of cutter (50). Cutter drivemechanism (310) of probe (305) thus operates like cutter drive mechanism(210) of probe (205).

A hollow bore (not shown) extends longitudinally within the hollow idlershaft (332) to concentrically surround (without interferingly touching)rotary shaft (353) of tissue holder rotational mechanism (340). Withthis coaxially nested arrangement, either one of tissue holderrotational mechanism (340) or cutter drive mechanism (310) may rotate orotherwise be actuated independently without affecting the other.

Turning now to FIG. 17, drive elements of cutter drive mechanism (310)and tissue holder rotational mechanism (340) can be seen placed withinbottom housing member (306). End connector (308) of cable sheath (319)is held within bottom housing member (306). Cable drive gear (325) andshock assembly (328) at a distal end of cable (317) are supported bybearings (326, 327) in bottom housing member (306). The assembly ofthumbwheel gear (350), rotary shaft (353), and takeoff gear (355) arerotatably supported in bearings (382) in bottom housing member (306). Adual plate support structure comprising a bottom plate (390) and a topplate (391) mounts within bottom housing member (306), with proximalbearing (383) received within to support rotary shaft (353) and takeoffgear (355). Takeoff gear (355) is shown nested within a clearance slot(392) within top plate (391) just proximal to proximal bearing (383).Intermediate gear (356) that rotatably engages with takeoff gear (355)is supported below takeoff gear (355). Drive gear (357), short driveshaft (359), and proximal takeoff gear (358) thus rotatably mountbetween bottom plate (390) and top plate (391). Gears (357, 358) can beseen protruding from top plate (391). Middle plate (321) and an encoderassembly (340) are not shown in FIG. 17.

As will be appreciated, tissue holder rotational mechanism (340) mayhave a variety of alternative features, components, configurations,functionalities, and methods of operations. Furthermore, tissue holderrotational mechanism (340) may have any other suitable relationshipswith cutter drive mechanism (210). Suitable alternatives will beapparent to those of ordinary skill in the art in view of the teachingsherein.

C. Exemplary Idler Shaft Encoder for Cutting Mechanism

As shown in FIG. 16, an encoder assembly (340) mounts to a proximal endof the idler shaft (332) and is operably connected to motor (530) viawiring (not shown) extending between holster (305) and vacuum controlmodule (500). Encoder assembly (340) may be configured and used in thesame way as encoder assembly (240) of holster (205) described above.Alternatively, encoder assembly (340) may be configured and/or used inany other suitable fashion, if not omitted altogether.

D. Exemplary Alternative Tissue Sample Holder

A probe (105) that is coupled with holster (305) may have tissue sampleholder (140) described above. Alternatively, as shown in FIG. 18, cup(141) of tissue sample holder (140) may be substituted with a splitremovable cup assembly (641), which may be coupled with probe (105) andholster (305), to provide an alternative tissue sample holder (640).Split removable cup assembly (641) of this example comprises a rotatingcup (655) that attaches to probe (105) over manifold (144). Cup (655) ismanually operable to rotate manifold (144) in this example. A lockingring (650) releasably attaches to probe (105), and rotatingly securescup (655) to probe (105). In particular, locking ring (650) secures cup(655) to probe (105) while permitting cup (655) to rotate relative tolocking ring (650) and probe (105). For instance, cup (655) and lockingring (650) may include complementary annular flanges (not shown) orother features to restrict longitudinal motion of cup (655) relative tolocking ring (650). Locking ring (105) does not move relative to probe(105) while cup (655) rotates in this example.

Rotating cup (655) has a proximal end wall (656) and a sidewall (657).Sidewall (657) and/or proximal end wall (656) may provide a graspingportion for the operator to grasp. Such a grasping portion may includetexture, bumps, ridges, or any other features to enhance grasping of thegrasping portion and rotation of rotating cup (655). Alternatively, afeature such as an integral knob or other protrusion may extendproximally from proximal end wall (656). A vacuum or fluid seal (660) isplaced between locking ring (650) and rotating cup (655), and maintainsfluid or vacuum integrity therebetween, both when cup (655) is rotatedrelative to ring (650) and when cup (655) is stationary relative to ring(650). Locking ring (650) may be configured with the previouslydescribed bayonet coupling (134) as shown in FIG. 3 for use as areleasable attachment mechanism to probe (105). Alternatively, any othersuitable structures or configurations may be used.

Split removable cup assembly (641) is further configured with one ormore inward extending drive members (658) to drivably engage withrotatable manifold (144), and when engaged, to rotate therewith. Drivemember (658) may comprise a keyed pin, a “D” shaft, a hex shaft, or anyother suitable structure, and may extend inward from an inside surfaceof proximal end wall (656) to drivingly engage with a drive hole (670)within rotatable manifold (144). When split removable cup assembly (641)is attached to bring drive member (658) into engagement with drive hole(670), and when manifold (144) rotates, rotating cup (655) rotatestherewith. Conversely, as described in detail below, rotation ofrotating cup (655) may rotate manifold (144).

As described above, gear (170) is secured to manifold (144), such thatgear (170) and manifold (144) rotate unitarily. As also described above,and with reference to FIG. 15, gear (170) is coupled with thumbwheel(60) via gears (358, 357, 356, 355, 350) and shafts (359, 353), suchthat gear (170) and thumbwheel rotate concomitantly. As also describedabove, and with reference to FIGS. 5-6, thumbwheel (60) is secured tocannula (12), such that rotation of thumbwheel (60) rotates cannula (12)(e.g., to angularly reorient aperture (16)). Accordingly, those ofordinary skill in the art will appreciate that an operator may manuallyrotate cup (655) to rotate cannula (12) (e.g., to angularly reorientaperture (16)).

To assemble split removable cup assembly (641), cup (655) may be placedover rotatable manifold (144) to engage drive member (658) of cup (655)with drive hole (670) in rotatable manifold (144). Once drive member(658) is engaged with drive hole (670), locking ring (650) may besecured to probe (105) by rotating locking ring (650) to engage bayonetcoupling (134). In this configuration, rotation of thumbwheel (60) onprobe (105) will rotate needle portion (10), manifold (144), androtating cup (655). If desired, the operator may rotate needle portion(10) by manually rotating the rotating cup (655).

Of course, a variety of other components, features, structures, andconfigurations may be used in addition to or in lieu of split removablecup assembly (641). By way of example only, manifold (144) may be fittedwith an integral and proximally extending knob (not shown) or otherfeature that protrudes through cup (141). Cup (141) may accommodate sucha knob or other feature with a seal, such that the knob or other featuremay rotate relative to cup (141) without causing loss of vacuum orfluids. In such versions, it will be understood that the operator mayrotate needle portion (10) by manually rotating the knob or otherfeature that extends proximally from manifold (144) through cup (141).In some other variations, tissue sample holder (140) is configured inaccordance with any of the teachings of U.S. Non-Provisional patentapplication Ser. No. 12/337,911, entitled “BIOPSY DEVICE WITH DISCRETETISSUE CHAMBERS,” filed on Dec. 18, 2008, the disclosure of which isincorporated by reference herein. Still other suitable components,features, structures, and configurations that may be used to permitrotation of needle portion from a tissue sample holder (140) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

E. Exemplary Method of Use of the Second Exemplary Biopsy Device

In a merely exemplary use of biopsy device (101), biopsy device (101) isassembled by operably coupling probe (105) with holster (305) and thenoperably coupling the assembled biopsy device (101) with vacuum controlmodule (500). With probe (105) attached to holster (305), thumbwheel(60) is rotatingly engaged with the tissue holder rotational mechanism(340) in holster (305), and is therefore rotatingly engaged withrotatable manifold (144) within tissue sample holder (140). Furthermore,with probe (105) attached to holster (305), gears (338, 84) are coupledsuch that cutter drive mechanism (310) within holster (350) is operablyengaged with cutter (50) within the probe (105). With the cable drivencutter drive mechanism (310) operably engaged with cutter (50), homingroutines may be performed, if required or desired, to identify a “home”position of cutter (50) within probe (105).

An operator then places biopsy device (101) into a grasping hand (1000)and/or couples biopsy device (101) with a fixture or targeting set.Needle portion (10) is then inserted into a patient's breast orelsewhere. The operator then rotates thumbwheel (60) with a thumb orother finger to achieve a desired angular orientation of aperture (16).Such rotation will also cause rotation of manifold (144). The operatorthen actuates cutter (50) to acquire a tissue sample, which iscommunicated to a tissue sample chamber (166) in tissue sample holder(140) via cutter lumen (52) and tissue sample passage (54). With needleportion (10) still inserted in the patient, the operator rotatesthumbwheel (60) to simultaneously reorient aperture (16) and indexanother tissue sample chamber (166) to tissue sample passage (54). Theoperator then actuates cutter (50) to acquire another tissue sample.This process may be repeated until a desired number of tissue samplesare obtained at a desired number of angular orientations about the axisdefined by needle portion (10). Of course, biopsy device (101) mayalternatively be used in any other desired fashion.

III. Third Exemplary Holster

FIGS. 19-20 show another exemplary holster (705). Holster (705) of thisexample is configured for use in a stereotactic setting. By way ofexample only, holster (705) may be coupled with probe (105), with aprobe as described in U.S. Pub. No. 2008/0195066, entitled “RevolvingTissue Sample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein, or with anyother suitable probe. Holster (705) comprises a top housing member(707), a bottom housing member (708), and a needle firing fork (790).Needle firing form (790) is positioned on the distal end of a needlefiring shaft (710), which extends distally from holster (705). Holster(705) further comprises hook members (714), which extend from tophousing member (707), and which may removably secure probe (105) toholster (705).

Top housing member (707) further comprises a recess (704) exposing athumbwheel gear (750). Thumbwheel gear (750) is configured to mesh withthumbwheel (60) when probe (105) is coupled with holster (705). Inparticular, thumbwheel gear (750) is operable to rotate in response tomanual rotation of thumbwheel (60) when probe (105) is coupled withholster (705). A tissue holder drive gear (751) extends from a proximalend of holster (705). Gear (751) is configured to mesh with gear (170)of tissue sample holder (140). In particular, gear (751) is operable torotate manifold (144) of tissue sample holder (140) when probe (105) iscoupled with holster (705), in the manner described above.

A linking mechanism (740) links thumbwheel gear (750) with gear (751).In particular, linking mechanism (740) is configured to cause gear (751)to rotate in response to rotation of thumbwheel gear (750). Linkingmechanism (740) of this example comprises a shaft (720) extendingproximally from thumbwheel gear (750). Another gear (722) is fixed toshaft (720). Gear (722) thus rotates with shaft (720) and with gear(750). Gear (722) also meshes with gear (724), which also meshes withgear (726). Gear (726) thus rotates with gears (722, 724). A shaft (728)extends proximally from gear (726). Another gear (730) is fixed to shaft(728). Gear (730) thus rotates with shaft (728) and with gear (726).Gear (730) also meshes with gear (732). A shaft (734) extends proximallyfrom gear (732). Another gear (736) is fixed to shaft (734). Gear (736)thus rotates with shaft (734) and with gears (730, 732). Gear (736) alsomeshes with gear (738), which also meshes with gear (740). Gear (740)thus rotates with gears (736, 738). A shaft (742) connects gear (740)with gear (751). Accordingly, thumbwheel gear (750) is coupled with gear(751) via gears (722, 724, 726, 730, 732, 736, 738, 740) and shafts(720, 728, 734, 742). Linking mechanism (740) is thus similar to tissueholder rotational mechanism (340) of holster (305). Of course, othersuitable components, features, configurations, and methods of operationfor a linking mechanism (740) such as the one in holster (705) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

It should also be understood that a probe (105) with tissue sampleholder (640) may be coupled with holster (705). In such a version,rotation of cup (655) may cause rotation of needle portion (10) asdescribed above, via linking mechanism (740) or otherwise.

A cutter drive mechanism (not shown) is also provided within holster(705). In particular, the cutter drive mechanism is operable to rotategear (238), which is exposed through top housing member (707). Gear(238) is configured to mesh with gear (85) when probe (105) is coupledwith holster (705). Accordingly, rotation of gear (238) causesconcomitant rotation and translation of cutter (50) when probe (105) iscoupled with holster (705). Exemplary components, features,configurations, and methods of operation for a cutter drive mechanismsuch as the one in holster (705) are described in U.S. Pub. No.2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein. Other suitable components, features,configurations, and methods of operation for a cutter drive mechanismsuch as the one in holster (705) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

A needle firing mechanism (not shown) is also provided within holster(705). In particular, the needle firing mechanism is operable to causeshaft (710) and fork (790) to translate longitudinally relative toholster (705). Fork (790) is configured to engage needle portion (10),such that needle portion (10) will translate longitudinally with shaft(710) and fork (790) when probe (105) is coupled with holster (705).Suitable modifications to probe (105) to permit needle portion (10) totranslate longitudinally relative to other components of probe (105)will be apparent to those of ordinary skill in the art in view of theteachings herein. Alternatively, any probe disclosed in U.S. Pub. No.2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein, may have its needle portion coupledwith and translated by fork (790). In either case, such firing of needleportion (10) may be desired to forcibly urge needle portion (10) intobreast tissue or other tissue. Exemplary components, features,configurations, and methods of operation for a needle firing mechanismsuch as the one in holster (705) are described in U.S. Pub. No.2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein. Other suitable components, features,configurations, and methods of operation for a needle firing mechanismsuch as the one in holster (705) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

IV. Fourth Exemplary Holster

FIGS. 21-22 show another exemplary holster (805), coupled with a probe(806). Probe (806) of this example is constructed in accordance with theteachings of U.S. Pub. No. 2008/0195066, entitled “Revolving TissueSample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein. Alternatively,holster (805) may be configured to couple with probe (105) or with anyother suitable probe. Probe (806) of the present example comprises aneedle portion (10) that has a tissue receiving aperture (16), likeprobe (105) described above. Probe (806) of the present example also hasa rotatable tissue sample holder (140), like probe (105) describedabove.

Holster (805) of the present example comprises hook members (814) thatare configured to removably secure probe (806) to holster (805). Holster(805) further comprises gears (850, 838) and inclined thumbwheels (810).Gear (850) is configured to mesh with a needle gear (not shown) of probe(806). Such a needle gear is secured to needle portion (10) of probe(806) such that needle portion (10) rotates with the needle gear.Examples of such a needle gear are disclosed in U.S. Pub. No.2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein, though any other types of needle gearsmay be used.

Gear (838) is configured to mesh with a cutter gear (not shown) of probe(806). In particular, probe (806) comprises a cutter rotation andtranslation mechanism (80) like probe (105), which presents the cuttergear through the bottom of probe. The cutter rotation and translationmechanism is operable to rotate and translate a cutter (50) withinneedle portion (10). Gear (838) is thus operable to actuate a cutter(50) within needle portion (10) of probe (806). A motor (not shown) orother mechanism may be provided within holster (805) to drive gear(838). Alternatively, gear (838) may be driven by a cable (217), such asin a manner similar to cable (217) driven techniques described herein.

The proximal end of holster (805) may also present a tissue sampleholder rotation gear (not shown), which may be configured to mesh with agear (170) of tissue sample holder (140) when probe (806) is coupledwith holster (805).

Thumbwheels (810) are coupled with gear (850) in this example, such thatthumbwheels (810) may be used to rotate needle portion (10). Inparticular, holster (805) includes a linking mechanism (not shown) thatlinks thumbwheels (810) with gear (850), such that rotation of eitherthumbwheel (810) causes concomitant rotation of needle portion (10).Suitable components, features, and configurations of such a linkingmechanism will be apparent to those of ordinary skill in the art in viewof the teachings herein. By way of example only, such a linkingmechanism may include a plurality of gears (e.g., one or more bevelgears), shafts, and/or universal joints. Such a linking mechanism mayalso be constructed similar to other such linking mechanisms describedherein.

It should also be understood that thumbwheels (810) may be coupled witha tissue sample holder rotation gear of holster (805). In particular,thumbwheels (810) may be linked with a tissue sample holder rotationgear such that rotation of either thumbwheel (810) causes concomitantrotation of manifold (144) within tissue sample holder (140). Suchcoupling may be provided by the same linking mechanism noted above,which couples thumbwheels (810) with gear (850), or by some otherlinking mechanism. Again, suitable components, features, andconfigurations for coupling thumbwheels (810) with a tissue sampleholder rotation gear will be apparent to those of ordinary skill in theart in view of the teachings herein.

In some versions of holster (805), one thumbwheel (810) is linked withgear (850), while the other thumbwheel (810) is linked with a tissuesample holder rotation gear. Holster (805) may thus have two or morelinking mechanisms, which may be either mechanically independent of eachother or somehow interdependent.

V. Fifth Exemplary Holster

FIG. 23 shows yet another exemplary holster (905). Holster (905) of thisexample may be coupled with probe (806), probe (105), or any othersuitable probe. Holster (905) comprises hook members (914) that areconfigured to removably secure probe (806, 105) with holster (905).Holster (905) further comprises gears (950, 938, 951), portions of whichare exposed by holster (905). Gear (950) is configured to mesh with aneedle gear (not shown) of probe (806). Such a needle gear is secured toneedle portion (10) of probe (806) such that needle portion (10) rotateswith the needle gear. Examples of such a needle gear are disclosed inU.S. Pub. No. 2008/0195066, entitled “Revolving Tissue Sample Holder ForBiopsy Device,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein, though any other types of needle gearsmay be used.

Gear (938) is configured to mesh with a cutter gear (not shown) of probe(806). In particular, probe (806) comprises a cutter rotation andtranslation mechanism (80) like probe (105), which presents the cuttergear through the bottom of probe. The cutter rotation and translationmechanism is operable to rotate and translate a cutter (50) withinneedle portion (10). Gear (938) is thus operable to actuate a cutter(50) within needle portion (10) of probe (806). A motor (not shown) orother mechanism may be provided within holster (905) to drive gear(938). Alternatively, gear (938) may be driven by a cable (217), such asin a manner similar to cable (217) driven techniques described herein.

The proximal end of holster (905) also presents tissue sample holderrotation gear (951), which is configured to mesh with a gear (170) oftissue sample holder (140) when probe (806) is coupled with holster(905).

A remote control (975) is coupled with holster (905) in this example viaa flexible drive cable assembly (980). Drive cable assembly (980)comprises a drive cable (not shown), much like drive cable (217)described above, with a surrounding sheath. In particular, the drivecable of drive cable assembly (980) is operable to communicate rotarymotion from remote control (975) to holster (905). Drive cable assembly(980) is also flexible, such that the drive cable of drive cableassembly (980) may still communicate rotary motion to holster (905) evenwhile being flexed, without binding. Remote control (975) comprises amanually rotatable thumbwheel (976) that is coupled with the drive cableof drive cable assembly (980). In particular, manual rotation ofthumbwheel (976) rotates the drive cable of drive cable assembly (980).

Thumbwheel (976) and the drive cable of drive cable assembly (980) arecoupled with gear (950) in this example, such that thumbwheel (976) maybe used to rotate needle portion (10) of a probe (806, 105) that iscoupled with holster (905). In particular, holster (905) includes alinking mechanism (not shown) that links thumbwheel (976) and the drivecable of drive cable assembly (980) with gear (950), such that rotationof thumbwheel (976) causes concomitant rotation of needle portion (10).Suitable components, features, and configurations of such a linkingmechanism will be apparent to those of ordinary skill in the art in viewof the teachings herein. By way of example only, such a linkingmechanism may include a plurality of gears (e.g., one or more bevelgears), shafts, and/or universal joints. Such a linking mechanism mayalso be constructed similar to other such linking mechanisms describedherein.

It should also be understood that thumbwheel (976) and the drive cableof drive cable assembly (980) may be coupled with tissue sample holderrotation gear (951). In particular, thumbwheel (976) and the drive cableof drive cable assembly (980) may be linked with tissue sample holderrotation gear (951) such that rotation of thumbwheel (976) causesconcomitant rotation of manifold (144) within tissue sample holder (140)of a probe (806, 105) that is mounted to holster (905). Such couplingmay be provided by the same linking mechanism noted above, which couplesthumbwheel (976) with gear (950), or by some other linking mechanism.Again, suitable components, features, and configurations for couplingthumbwheel (976) with a tissue sample holder rotation gear will beapparent to those of ordinary skill in the art in view of the teachingsherein

It should also be understood that drive cable assembly (980) may be ofany suitable length. For instance, drive cable assembly (980) may beless than one foot long, four feet long, ten feet long, or any othersuitable length.

VI. Exemplary Vacuum Control Module and Canister

As shown in FIG. 1, an exemplary vacuum canister (600) is configured tobe coupled vacuum control module (500). Vacuum control module (500) isoperable to induce a vacuum through vacuum canister (600), and such avacuum may be communicated to probe (105) via tubes (502, 504). Forinstance, vacuum control module (500) may communicate a vacuum throughtube (502), which may then communicate the vacuum through tissue sampleholder (140) to cutter lumen (52) as described above. Vacuum controlmodule (500) may also communicate a vacuum through tube (504) tomanifold (70), which may then communicate the vacuum to vacuum lumen(40) as described above.

Furthermore, vacuum canister (600) is operable to collect fluids thatare communicated from biopsy probe (105) during use of biopsy probe(105). Vacuum canister (600) may thus be regarded as providing a fluidinterface between biopsy probe (105) and vacuum control module (500).Any suitable vacuum control module and vacuum canister may be used suchas those described in U.S. Pub. No. 2008/0195066, entitled “RevolvingTissue Sample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein. Further, anyother suitable component, system, technique, or device may be used withthe suitable control module or vacuum canister.

As noted above, vacuum control module (500) of the present example alsoincludes a motor (503) that is operable to rotate cable (217), such asto actuate cutter (50) as described above. By way of example only, motor(503) may be associated with vacuum control module (400) as taught inU.S. Non-Provisional patent application Ser. No. 12/337,814, entitled“CONTROL MODULE INTERFACE,” filed on Dec. 18, 2008, the disclosure ofwhich is incorporated by reference herein. Of course, the features andfunctionality of vacuum control module (500) and vacuum canister (600)as described herein are mere examples.

VII. Exemplary Modes of Operation

It will be appreciated in view of the disclosure herein that there are avariety of methods by which biopsy system (2) may be operated. Forinstance, regardless of the structures or techniques that are used toselectively control communication of fluid (e.g., saline, vacuum,venting, etc.), through conduits (501) or otherwise within biopsy system(2), there are a variety of timing algorithms that may be used. Suchtiming algorithms may vary based on an operational mode selected by auser. Furthermore, there may be overlap among operational modes (e.g.,biopsy system (2) may be in more than one operational mode at a givenmoment, etc.). In addition to fluid communication timing algorithmsbeing varied based on a selected mode of operation, other operationalaspects of biopsy system (2) may vary based on a selected operationalmode. Several merely exemplary operational modes exist, while otherswill be apparent to those of ordinary skill in the art in view of theteachings herein. Any suitable operational mode may be used include forexample any suitable mode disclosed in U.S. Pub. No. 2008/0195066,entitled “Revolving Tissue Sample Holder For Biopsy Device,” publishedAug. 14, 2008, the disclosure of which is incorporated by referenceherein.

One exemplary operation of biopsy system (2) will now be explained whereneedle portion (10) has been inserted into the breast of a patient. Withneedle portion (10) inserted, lateral and axial vacuum are applied. Inparticular, a vacuum is communicated through tubes (502, 504). Given thefluid connection of tube (504) with vacuum lumen (40) of outer cannula(12), communication of a vacuum through tube (504) will draw a lateralvacuum relative to cannula lumen (20). Communication of a vacuum throughtube (502) will draw an axial vacuum through cutter lumen (52), giventhe fluid connection of tube (502) to cutter lumen (52) via tissuesample holder (140) and passage (54) in this example.

With the axial and lateral vacuum applied as described above, cutter(50) is retracted axially. The axial retraction of cutter (50) willserve to “open” aperture (16), which results in tissue prolapsing intoaperture (16) under the influence of the above-described vacuums. Cutter(50) may dwell in a retracted position for a certain period of time toensure sufficient prolapse of tissue.

Next, cutter (50) is advanced distally to sever tissue that is prolapsedthrough aperture (16). As the distal end of cutter (50) passes thedistal edge of aperture (16), such that cutter (50) “closes” aperture(16), the prolapsed tissue should be severed and at least initiallycontained within cutter lumen (52). Transverse openings (32) should beconfigured such that at least one or more of openings (32) are notcovered by cutter (50) when cutter (50) has reached a position to“close” aperture (16). With aperture (16) closed and a vent beingprovided by transverse openings (32) through tube (504), an axial vacuumbeing communicated through cutter lumen (52) by tube (502) should drawthe severed tissue sample proximally through cutter lumen (52) and intoa tissue sample chamber (166) of tissue sample holder (140). Cutter (50)may be reciprocated one or more times through a slight range of motionat a distal position to sever any remaining portions that may have notbeen completely severed in the first pass of cutter (50).

Before tissue sample is communicated proximally through cutter lumen(52), with aperture (16) being closed by cutter (50), vacuum lumen (40)being vented by tube (504), and an axial vacuum being provided by tube(502) via cutter lumen (52), cutter (50) is retracted slightly to exposea portion of aperture (16) for a short period of time. During this time,saline may be provided at atmospheric pressure to vacuum lumen (40) bytube (504). Further retraction of cutter (50) exposes more transverseopenings (32), thereby increasing fluid communication between vacuumlumen (40) and cannula lumen (20). Retraction of cutter (50) alsoexposes the pressure of the tissue cavity (from which tissue sample wasobtained) to the distal surface of tissue sample. As a result of theslight retraction of cutter (50) in this particular example, thelikelihood of atmospheric pressure being applied to the distal face oftissue sample may be increased to help ensure that severed tissue sampledoes not remain in needle portion (10) (a.k.a. a “dry tap”). Cutter (50)is then fully advanced distally, closing both aperture (16) and alltransverse openings of outer cannula (12). Such “closure” of transverseopenings may ensure that if medication is applied at this time (betweensamples) to reduce pain, it will reach the breast cavity throughexternal openings in outer cannula (12) instead of being aspiratedthrough transverse openings and through cutter lumen (52) and tissuesample holder (140).

With the cutter (50) being completely advanced (e.g., such that alltransverse openings and aperture (16) are closed), and severed tissuesample being communicated proximally through cutter lumen (52) and intoa tissue sample chamber (166) by an axial vacuum drawn by tube (502),biopsy device (100) will be in a ready state. In this ready state,vacuum lumen (40) is vented to atmosphere, and axial vacuum tube (502)is sealed (a.k.a. “dead-headed”).

Other suitable components of, features of, configurations of, andmethods of operating biopsy system (2) are disclosed in U.S. Pub. No.2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein. Still other suitable components of,features of, configurations of, and methods of operating biopsy system(2) will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Embodiments of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Embodiments of the devices disclosed herein can be designed to bedisposed of after a single use, or they can be designed to be usedmultiple times. Embodiments may, in either or both cases, bereconditioned for reuse after at least one use. Reconditioning mayinclude any combination of the steps of disassembly of the device,followed by cleaning or replacement of particular pieces, and subsequentreassembly. In particular, embodiments of the device may bedisassembled, and any number of the particular pieces or parts of thedevice may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, embodiments of thedevice may be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device may utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

By way of example only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1-20. (canceled)
 21. An MRI compatible biopsy device for use in an MRIguided biopsy procedure, the biopsy device comprising: (a) an MRIcompatible probe, wherein the probe includes: (i) a body portion, (ii) aneedle extending distally from the body portion, wherein the needledefines a longitudinal axis and a transverse tissue receiving feature,wherein the tissue receiving feature is operable to rotate relative tothe body portion, and (iii) a cutter, wherein the cutter is movablerelative to the tissue receiving feature to sever one or more tissuesamples; (b) a tissue sample holder, wherein the tissue sample holder isconfigured to receive a plurality of tissue samples severed by thecutter; and (c) a leveler, wherein the leveler is positioned on an outersurface of the body portion of the probe, wherein the leveler isresponsive to the force of gravity to provide an indication to anoperator of the position of the body portion of the probe relative togravity.
 22. The biopsy device of claim 21, further comprising at leastone rotatable thumbwheel, wherein the at least one rotatable thumbwheelis in communication with the needle to rotate the needle axiallyrelative to the longitudinal axis defined by the needle.
 23. The biopsydevice of claim 22, wherein the at least one thumbwheel extendsgenerally proximally at an oblique angle relative to the longitudinalaxis defined by the needle.
 24. The biopsy device of claim 23, furthercomprising a holster, wherein the holster is configured to couple withthe body portion of the probe, wherein the at least one thumbwheelextends from the holster.
 25. The biopsy device of claim 22, furthercomprising a linking mechanism, wherein the tissue sample holder furtherincludes a rotatable member, wherein the linking mechanism is configuredto link rotation of the needle via the at least one thumbwheel withrotation of the rotatable member of the tissue sample holder.
 26. Thebiopsy device of claim 25, wherein the rotatable member of the tissuesample holder defines a plurality of chambers, wherein the at least onethumbwheel is configured to index a next adjacent chamber of theplurality of chambers of the rotatable member with the needle uponrotation of the at least one thumbwheel.
 27. The biopsy device of claim25, wherein the tissue receiving feature of the needle is configured todirectly correlate to rotation of the rotatable member of the tissuesample holder.
 28. The biopsy device of claim 25, wherein the tissuereceiving feature of the needle is configured to rotate at substantiallythe same rotational angle as the rotatable member of the tissue sampleholder.
 29. The biopsy device of claim 21, wherein the cutter isrotatably and translatably moveable within the needle to sever tissuedrawn into the tissue receiving feature, wherein the cutter defines acutter lumen.
 30. The biopsy device of claim 29, wherein a vacuum sourceis in communication with the cutter lumen, wherein the tissue sampleholder is configured to receive tissue samples communicated through thecutter lumen.
 31. The biopsy device of claim 21, further comprising aremote control positioned remotely from the probe, wherein the remotecontrol is in communication with the probe by a flexible drive cable.32. The biopsy device of claim 31, wherein the remote control includesat least one rotatable thumbwheel, wherein the at least one thumbwheelis accessible to an operator such that the at least one thumbwheel isconfigured to be manually operable to rotate the needle about thelongitudinal axis.
 33. The biopsy device of claim 21, wherein theleveler includes a tube, wherein the tube is partially embedded in anupper portion of the body portion of the probe.
 34. The biopsy device ofclaim 33, wherein the tube is filled with a fluid, wherein the fluiddefines a bubble, wherein the fluid is configured to respond to theforce of gravity to provide the indication via the bubble to an operatorof the position of the body portion of the probe relative to gravity.35. The biopsy device of claim 21, wherein leveler defines alongitudinal axis, wherein the longitudinal axis of the leveler isparallel with the longitudinal axis defined by the needle.
 36. An MRIcompatible biopsy device for use in an MRI guided biopsy procedure,comprising: (a) an MRI compatible probe, wherein the probe includes: (i)a body portion, and (ii) a needle extending distally from the bodyportion, wherein the needle defines a longitudinal axis and a transversetissue receiving feature; (b) a tissue sample holder including aplurality of passages, wherein the tissue sample holder is rotatablerelative to the body portion of the probe to successively align eachpassage of the plurality of passages with the needle; and (c) anleveler, wherein the leveler is positioned on the body portion such thatat least a portion of the leveler is configured to move relative to thebody to provide a visual indication of a position of the body portionrelative to a horizontal axis.
 37. The biopsy device of claim 36,wherein the leveler includes a bubble level.
 38. The biopsy device ofclaim 36, wherein the leveler is positioned adjacent to a proximal endof the body portion of the probe.
 39. The biopsy device of claim 36,wherein the leveler is positioned along a level axis, wherein the levelaxis is parallel with the longitudinal axis defined by the needle. 40.An MRI compatible biopsy device for use in an MRI guided biopsyprocedure, comprising: (a) an MRI compatible probe; (b) a needleextending distally from the probe, wherein the needle defines alongitudinal axis and a transverse tissue receiving feature; (c) acutter, wherein the cutter is movable relative to the needle to severtissue extending through the transverse tissue receiving feature of theneedle; and (d) a leveler, wherein the leveler is disposed on a topsurface of the body portion of the probe, wherein the leveler isconfigured to indicate whether the biopsy device is positioned at apredetermined angle relative to a force of gravity.